UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033783
Receipt No. R000038538
Scientific Title muscle volume change by ICU-acquired weakness with/without high dose protein and electrical muscle stimulation
Date of disclosure of the study information 2018/08/16
Last modified on 2018/08/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title muscle volume change by ICU-acquired weakness with/without high dose protein and electrical muscle stimulation
Acronym protein dose and electrical muscle stimulation for ICU-AW
Scientific Title muscle volume change by ICU-acquired weakness with/without high dose protein and electrical muscle stimulation
Scientific Title:Acronym protein dose and electrical muscle stimulation for ICU-AW
Region
Japan

Condition
Condition ICU-AW
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to investigate the efficacy of protein dose and electrical muscle stimulation for ICU-AW
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes femoral muscle volume change (evaluated by computed tomography)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 In the first period, enteral nutrition after admission is performed by high protein group: Peptamen Intense for ten days.
Interventions/Control_2 In the first period, enteral nutrition after admission is performed by normal group: Glucerna REX for ten days.
Interventions/Control_3 In the latter period, all patients are treated with electrical muscle stimulation, and enteral nutrition after admission is performed by high protein group: Peptamen Intense for ten days.
Interventions/Control_4 In the latter period, all patients are treated with electrical muscle stimulation, and enteral nutrition after admission is performed by normal group: Glucerna REX for ten days.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 admission to ICU
2 age >=20
3 able to perform enteral nutrition
4 get the informed consent
Key exclusion criteria 1 age <20
2 young female who can get pregnant
3 can not get the informed consent
4 the other inadequate patients
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kensuke Nakamura
Organization Hitachi General Hospital
Division name Emergency and Critical Care Medicine
Zip code
Address 2-1-1 Jonancho Hitachi Ibaraki Japan
TEL +81294231111
Email mamashockpapashock@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kensuke Nakamura
Organization Hitachi General Hospital
Division name Emergency and Critical Care Medicine
Zip code
Address 2-1-1 Jonancho Hitachi Ibaraki Japan
TEL +81294231111
Homepage URL
Email mamashockpapashock@yahoo.co.jp

Sponsor
Institute Hitachi General Hospital
Emergency and Critical Care Medicine
Institute
Department

Funding Source
Organization no funding source
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 08 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 16 Day
Last modified on
2018 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038538

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.